Colorectal Cancer
Conditions
Keywords
Pomegranate, Urolithins, Colorectal cancer, Colon cancer, Metabolite, Gene expression, microRNA, Nutraceutical, Food supplement, Polyphenol, Gut microbiota
Brief summary
The most relevant pomegranate phenolics (ellagitannins and ellagic acid) are extensively metabolized by the human gut microbiota to yield a number of metabolites called urolithins (mainly Uro-A). Urolithins have been reported to regulate in vivo the expression of genes involved in inflammation and cancer. Our hypothesis is that urolithins can be detected in the human colon mucosa where these metabolites can exert anti-inflammatory and anti-cancer activities. After colonoscopy and diagnosis, colorectal cancer patients will consume capsules containing three different pomegranate extract formulations until surgery. The aims of this trial are: * To evaluate the disposition of pomegranate phenolics and urolithins in tumoral and normal colon tissues. * To evaluate gene expression profiling and protein markers in tumoral and normal colon tissues from these patients. * To compare different pomegranate extract formulations on the above.
Interventions
DIETARY_SUPPLEMENTStandard pomegranate extract formulation
Standard pomegranate extract formulation containing 20% punicalagin
DIETARY_SUPPLEMENTPomegranate extract formulation-1
New pomegranate extract formulation-1
DIETARY_SUPPLEMENTPomegranate extract formulation-2
New pomegranate extract formulation-2
Sponsors
Hospital Universitario Reina Sofia de Cordoba
National Research Council, Spain
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Colorectal cancer diagnosis. * Surgery required. * WHO status: between 0 and 2. * Hemoglobin \>10 g/dL * ALT \>2.5-fold above the normal value. * Serum Bilirubin \>1.5-fold above the normal value. * Creatinine \<140 micromol/L
Exclusion criteria
* Patients who do not satisfy inclusion criteria and, * Active pectic ulcer. * Pregnancy or breastfeeding. * Alcoholism. * Chemotherapy or radiotherapy a month prior to recruitment. * Treatment with steroids or other anti-inflammatory drugs a week prior to recruitment.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Phenolics and derived metabolites in colon tissues, plasma and urine. | Change from baseline at 15 days | Occurrence of phenolics and gut-microbiota derived metabolites in tumoral and colon tissues, urine and plasma. |
| Gene expression profiling in colon tissues | Change from baseline at 15 days | Gene expression profile changes in tumoral and normal colon tissues |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| IGF-1 (insulin-like growth factor-1) | Change from baseline at 15 days | Change in circulating IGF-1 levels |
| CEA (carcnoembryonic antigen) | Change from baseline at 15 days | Change in circulating CEA levels |
| Number of patients with adverse events as a measure of safety and tolerability | Change from baseline at 15 days | * Change in markers involved in hepatic and renal functions: GGT, AST, ALP, ALT, CPK, urate, creatinin, albumin, bilirubin, LDH. * Change in hematological variables: leucocytes, neutrophils, lymphocytes, monocytes, eosinophils, basophils, hemoglobin, hematocrit, mean corpuscular volume, mean platelet volume, platelets, mean corpuscular hemoglobin, mean corpuscular hemoglobin concentration. * Intolerance, dyspepsia, allergic reactions, constipation, diarrhea, abdominal pain, nausea. |
| microRNA expression profiling in colon tissues | Change from baseline at 15 days | microRNA (miR) expression profile change in tumoral and normal colon tissues |
Countries
Spain
Outcome results
None listed